Fibromuscular DysplasiaPROFILENCT02961868
Cohort Follow-up of Patients With Renal or Craniocervical Fibromuscular Dysplasia
A study testing Abdominal and supra-aortic trunks vascular imaging, Blood sampling (genetic) and Blood sampling (biomarkers) in people with Fibromuscular Dysplasia, run by Assistance Publique - Hôpitaux de Paris at 17 sites in 2 countries.
Trial summary
PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromuscular Dysplasia
- What is being tested?
- Abdominal and supra-aortic trunks vascular imaging, Blood sampling (genetic) and Blood sampling (biomarkers)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Nov 2009to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with renal or craniocervical fibromuscular dysplasia diagnosed during the 2 years before inclusion
- The fibromuscular dysplasia is documented by imaging (angiography, CT-angiography, MR-angiography) of less than 2 years and validated by a radiologist investigator
- Patient who understood and signed inform consent form
- Affiliated to the French health insurance system
- Available for a 3 years follow-up
Who cannot join
- Patient with renal or craniocervical atherosclerosis, or inflammatory vascular disease as dominant pathological features
- Patient with renal or craniocervical arteries dissection or aneurysm without any other evidence of fibromuscular dysplasia
- Patient under 18 or under tutorship
- Known pregnancy
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
France16 sites
CHU de Bordeaux hopital Saint-Andre
Bordeaux, Aquitaine-Limousin-Poitou-Charentes, 33000
CHU de Caen hopital Cote de Nacre
Caen, Normandy, 14000
CHU de Clermont-Ferrand hopital Gabriel-Montpied
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000
CHU de Grenoble hopital Albert-Michallon
La Tronche, Auvergne-Rhône-Alpes, 38700
Centre Hospitalier de Versailles hopital Andre Mignot
Le Chesnay, Île-de-France Region, 78157
CHRU de Lille hopital cardiologique
Lille, Hauts-de-France, 59000
CHRU de Lille hopital Roger-Salengro
Lille, Hauts-de-France, 59000
AP-HM hopital de la Timone
Marseille, Provence-Alpes-Côte d'Azur Region, 13385
AP-HP hopital Lariboisiere
Paris, Île-de-France Region, 75010
AP-HP hopital Pitie-Salpetriere
Paris, Île-de-France Region, 75013
Centre hospitalier Sainte-Anne
Paris, Île-de-France Region, 75014
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75015
AP-HP hopital Bichat-Claude-Bernard
Paris, Île-de-France Region, 75018
AP-HP hopital Tenon
Paris, Île-de-France Region, 75020
CHU de Toulouse hopital Rangueil
Toulouse, Occitanie, 31000
CHU de Nancy institut Louis-Mathieu
Vandeuvre-les-Nancy, Grand Est, 54500
Belgium1 site
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200
About this study
Official title: PROgression of FIbromuscular LEsions
PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia.
Read the detailed description
Background
Fibromuscular dysplasia (FMD) is a group of nonatherosclerotic, noninflammatory arterial diseases that usually involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. The prevalence of FMD in hypertensive patients is estimated at 4/1000. Angiographic classification includes the multifocal type, with multiple stenoses and the 'string-of-beads' appearance that is related to medial FMD, and tubular and focal types which are not clearly related to specific histological lesions. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD appears to be familial in 10% of cases (OMIM #135580).
Renal artery FMD may progress to more severe stenosis and to renal atrophy, and/or to stenoses affecting more arteries within or outside the renal vasculature. The risk of progression as assessed from available studies was probably overestimated because documentation of progression was obtained from angiography, a procedure which is not routinely undertaken in patients with favourable clinical and biological outcomes. The disease is progressive, however, and literature stated that patients with FMD should undergo yearly duplex ultrasonography to detect progression of disease, restenosis, or loss of kidney volume.
There are very few data on prognosis of patients with symptomatic carotid or vertebral artery FMD. The risk of arterial disease progression over time is unknown. The risk of ischemic stroke ranged from 0 to about 3% per year in the few studies which assessed that issue.
Objectives
The primary objective is to estimate the incidence and risk factors for progression of FMD lesions. This will be assessed by comparison between initial and 3 years abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or Magnetic Resonance (MR) angiography), monitoring of downstream consequences development of lesions progression and clinical events.
The secondary objectives are:
- to estimate rate of genetic polymorphism that may influence disease progression or be associated with complications
- to assess the frequency of multi-site FMD (common objective with the ARCADIA study)
- to collect standardized clinical, radiological, and biological data in patients with FMD through a national registry (common objective with the ARCADIA study)
- to organize a clinical, radiological and biological database and a biobank that will constitute a unique resource to initiate further clinical research (common objective with the ARCADIA study).
- Conditions
- Fibromuscular Dysplasia
- Being tested
- Abdominal and supra-aortic trunks vascular imaging, Blood sampling (genetic), Blood sampling (biomarkers), Urine sampling
- Keywords
- Renal Artery Obstruction, Carotid Artery Diseases, Genetic Association Studies
- Medical subject headings
- Fibromuscular Dysplasia, Renal Artery Obstruction, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal and supra-aortic trunks vascular imagingOther
Abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or MR-angiography) will be performed 3 years after inclusion. This imaging will be compare to initial imaging (which is a part of usual care, not an intervention added by the study) in order to assess FMD progression.
Blood sampling (genetic)Genetic
A sample of blood will be taken to meet the objective of estimating the rate of genetic polymorphism that may influence disease progression or be associated with complications.
Blood sampling (biomarkers)Other
A sample of blood will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.
Urine samplingOther
A sample of urine will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Experimental | 3 years follow-up Receives: Other: Abdominal and supra-aortic trunks vascular imaging; Genetic: Blood sampling (genetic); Other: Blood sampling (biomarkers); Other: Urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of fibromuscular dysplasia lesions confirmed by imaging
Measured: 3 years
Secondary outcomes (11)
Glomerular filtration rate (GFR)
Measured: Inclusion, 3 years
Kidney height
Measured: Inclusion, 3 years
Clinical event: revascularization procedure in a lesion site
Measured: Through study completion
Clinical event: renal infarction
Measured: Through study completion
Clinical event: ischemic stroke
Measured: Through study completion
Clinical event: arterial dissection in a lesion site or downstream from a lesion site
Measured: Through study completion
Clinical event: aneurysm rupture in a lesion site or downstream from a lesion site
Measured: Through study completion
Prevalence of multisite fibromuscular dysplasia confirmed by imaging
Measured: Inclusion, 3 years
Single nucleotide polymorphisms
Assessed by genome-wide association
Measured: Inclusion
Plasminogen/plasmin level
Measured: Inclusion
Matrix metalloproteinases level
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2009
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromuscular DysplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de Recherche sur l'Hypertension Artérielle
- Responsible party
- Sponsor
- Investigators
- Pierre-François Plouin, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961868
- Sponsor's protocol ID
- P071241
- Other IDs
- P071241, 2009-A00288-49, PHRC-08-192
- Acronym
- PROFILE
- Status last verified
- Sep 2019
- First submitted
- 7 Nov 2016
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROgression of FIbromuscular LEsions
- ClinicalTrials.gov ID
- NCT02961868
- Acronym / sponsor ID
- PROFILE / P071241
- Conditions
- Fibromuscular Dysplasia
- Keywords
- Renal Artery Obstruction, Carotid Artery Diseases, Genetic Association Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation de Recherche sur l'Hypertension Artérielle
- Study start
- Nov 2009 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia.
Detailed description
Background
Fibromuscular dysplasia (FMD) is a group of nonatherosclerotic, noninflammatory arterial diseases that usually involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. The prevalence of FMD in hypertensive patients is estimated at 4/1000. Angiographic classification includes the multifocal type, with multiple stenoses and the 'string-of-beads' appearance that is related to medial FMD, and tubular and focal types which are not clearly related to specific histological lesions. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD appears to be familial in 10% of cases (OMIM #135580).
Renal artery FMD may progress to more severe stenosis and to renal atrophy, and/or to stenoses affecting more arteries within or outside the renal vasculature. The risk of progression as assessed from available studies was probably overestimated because documentation of progression was obtained from angiography, a procedure which is not routinely undertaken in patients with favourable clinical and biological outcomes. The disease is progressive, however, and literature stated that patients with FMD should undergo yearly duplex ultrasonography to detect progression of disease, restenosis, or loss of kidney volume.
There are very few data on prognosis of patients with symptomatic carotid or vertebral artery FMD. The risk of arterial disease progression over time is unknown. The risk of ischemic stroke ranged from 0 to about 3% per year in the few studies which assessed that issue.
Objectives
The primary objective is to estimate the incidence and risk factors for progression of FMD lesions. This will be assessed by comparison between initial and 3 years abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or Magnetic Resonance (MR) angiography), monitoring of downstream consequences development of lesions progression and clinical events.
The secondary objectives are:
- to estimate rate of genetic polymorphism that may influence disease progression or be associated with complications
- to assess the frequency of multi-site FMD (common objective with the ARCADIA study)
- to collect standardized clinical, radiological, and biological data in patients with FMD through a national registry (common objective with the ARCADIA study)
- to organize a clinical, radiological and biological database and a biobank that will constitute a unique resource to initiate further clinical research (common objective with the ARCADIA study).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | Experimental | Other: Abdominal and supra-aortic trunks vascular imaging, Genetic: Blood sampling (genetic), Other: Blood sampling (biomarkers), Other: Urine sampling3 years follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with renal or craniocervical fibromuscular dysplasia diagnosed during the 2 years before inclusion
- The fibromuscular dysplasia is documented by imaging (angiography, CT-angiography, MR-angiography) of less than 2 years and validated by a radiologist investigator
- Patient who understood and signed inform consent form
- Affiliated to the French health insurance system
- Available for a 3 years follow-up
Key exclusion criteria (4 listed)
- Patient with renal or craniocervical atherosclerosis, or inflammatory vascular disease as dominant pathological features
- Patient with renal or craniocervical arteries dissection or aneurysm without any other evidence of fibromuscular dysplasia
- Patient under 18 or under tutorship
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal and supra-aortic trunks vascular imagingAbdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or MR-angiography) will be performed 3 years after inclusion. This imaging will be compare to initial imaging (which is a part of usual care, not an intervention added by the study) in order to assess FMD progression. | Other | Prospective cohort |
| Blood sampling (genetic)A sample of blood will be taken to meet the objective of estimating the rate of genetic polymorphism that may influence disease progression or be associated with complications. | Genetic | Prospective cohort |
| Blood sampling (biomarkers)A sample of blood will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions. | Other | Prospective cohort |
| Urine samplingA sample of urine will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions. | Other | Prospective cohort |
Primary outcome
Progression of fibromuscular dysplasia lesions confirmed by imaging
Time frame: 3 years
11 secondary outcomes
Glomerular filtration rate (GFR)
Time frame: Inclusion, 3 years
Kidney height
Time frame: Inclusion, 3 years
Clinical event: revascularization procedure in a lesion site
Time frame: Through study completion
Clinical event: renal infarction
Time frame: Through study completion
Clinical event: ischemic stroke
Time frame: Through study completion
Clinical event: arterial dissection in a lesion site or downstream from a lesion site
Time frame: Through study completion
Clinical event: aneurysm rupture in a lesion site or downstream from a lesion site
Time frame: Through study completion
Prevalence of multisite fibromuscular dysplasia confirmed by imaging
Time frame: Inclusion, 3 years
Single nucleotide polymorphisms
Time frame: Inclusion
Plasminogen/plasmin level
Time frame: Inclusion
Matrix metalloproteinases level
Time frame: Inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-François Plouin, MD principal investigator
Assistance Publique - Hôpitaux de Paris
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal and supra-aortic trunks vascular imaging, Blood sampling (genetic) and Blood sampling (biomarkers) in people with Fibromuscular Dysplasia, run by Assistance Publique - Hôpitaux de Paris at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of fibromuscular dysplasia lesions confirmed by imaging (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.